FDA.reportPublic FDA data

Acne Gel Pen

Product NDC
71714-004
11-digit product format
717140004
Labeler code
71714
Product ID
71714-004_5d305187-3783-b840-e063-6394a90a1593
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
Tiege Hanley
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-31
Substance
SALICYLIC ACID
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Acne Gel Pen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID20 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71714-004-01Acne Gel Pen1.3 mL in 1 TUBE, WITH APPLICATORGEL1.31

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 32 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zitlox Salicylic AcneSALICYLIC ACIDASA Universal Inc. dba: SONAGE4b833d7a-f957-4e65-be5b-1771493149582025-01-06WarningsExact identifier
application number: M006
glo SKIN BEAUTY Clear Skin CleanserGLO SKIN BEAUTY CLEAR SKIN CLEANSERHayden Caleel LLC07f51d83-e956-442c-9afa-aa987a66ae9e2025-01-05WarningsExact identifier
application number: M006
glo SKIN BEAUTY Clear Skin Spot TreatmentGLO SKIN BEAUTY CLEAR SKIN SPOT TREATMENTHayden Caleel LLC9f33ffc7-2727-491e-a361-7f130c81d1b12025-01-05WarningsExact identifier
application number: M006
Acne Defense Face WashSALICYLIC ACIDPacifica Beauty, LLCf43590c7-84c0-6eb8-e053-2a95a90a01a72025-01-03WarningsExact identifier
application number: M006
Acne Warrior Body ScrubSALICYLIC ACIDPacifica Beauty, LLCf44a4fc5-3358-5966-e053-2995a90add562025-01-03WarningsExact identifier
application number: M006
Acne Warrior Body WashSALICYLIC ACIDPacifica Beauty, LLCf45b4c77-45a3-f480-e053-2995a90a36be2025-01-03WarningsExact identifier
application number: M006
Acne Warrior Clearing AstringentSALICYLIC ACIDPacifica Beauty, LLCf44bcd96-dbf8-5718-e053-2a95a90adc342025-01-03WarningsExact identifier
application number: M006
Dry It Out Acne Spot TreatmentSALICYLIC ACIDPacifica Beauty, LLCf44c0be7-9565-0068-e053-2a95a90a97052025-01-03WarningsExact identifier
application number: M006
Pacifica Bacne WarriorSALICYLIC ACIDPacifica Beauty, LLCf2b77c4f-f181-76cb-e053-2995a90a6cc12025-01-03WarningsExact identifier
application number: M006
Clarifying BacneSALICYLIC ACIDDermalogica, LLC.eb13bf93-2554-4666-bd74-637b2eed7b502025-01-02WarningsExact identifier
application number: M006
CLN ACNE CLEANSERSALICYLIC ACID 0.5% LIQUIDTopMD Skin Care, Inc.1b2f4718-b174-9b50-e063-6394a90ac2f42025-01-02WarningsExact identifier
application number: M006
Biore Witch Hazel Pore Clarifying CleanserSALICYLIC ACIDKao USA Inc.7c107414-457b-1ab0-e053-2991aa0af55a2025-01-01WarningsExact identifier
application number: M006
Biore Blemish Fighting Ice CleanserSALICYLIC ACIDKao USA Inc.e105ed47-d161-4563-a05f-f2e245659aee2025-01-01WarningsExact identifier
application number: M006
CLENZIDERM PORE THERAPY ACNE TREATMENTSALICYLIC ACIDObagi Cosmeceuticals LLC08c1a55e-a376-4cd6-896f-0ad2068a1fc02025-01-01WarningsExact identifier
application number: M006
CLENZIDERM THERAPEUTIC MOISTURIZERGLYCERINObagi Cosmeceuticals LLCd60e22e3-831e-4787-a82c-e7763c2875532025-01-01WarningsExact identifier
application number: M006
CLENZIDERM DAILY CARE FOAMING CLEANSER ACNE TREATMENTSALICYLIC ACIDObagi Cosmeceuticals LLC268bf278-3f18-4410-b552-25baadb9f96c2025-01-01WarningsExact identifier
application number: M006
CLENZIDERM THERAPEUTICBENZOYL PEROXIDEObagi Cosmeceuticals LLCf0ad29b6-38b0-4118-a711-3c668ac801ec2025-01-01WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION CONCEALERSALICYLIC ACIDALMAY2a932c8f-3a48-dfcd-e063-6394a90ac20b2024-12-31WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION CONCEALERSALICYLIC ACIDALMAY2a9315ce-f4da-6a1e-e063-6294a90a8f422024-12-31WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION CONCEALERSALICYLIC ACIDALMAY2a92bd47-0d91-00b9-e063-6294a90ae1d62024-12-31WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
346298salicylic acid 2 % Topical GelPSN4176d9b1-ca93-a6c4-e063-6394a90a68fb1
346298salicylic acid 0.02 MG/MG Topical GelSCD4176d9b1-ca93-a6c4-e063-6394a90a68fb1
346298salicylic acid 2 % Topical GelSY4176d9b1-ca93-a6c4-e063-6394a90a68fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71714-004-01717140004011.3 mL in 1 TUBE, WITH APPLICATOR (71714-004-01) 1.3 ml2025-10-31NoNoCurrent